WASHINGTON, May 2 (UPI) -- The U.S. Food and Drug Administration has formally asked Shelhigh Inc. to recall all its medical devices because of sterility concerns.
U.S. marshals earlier this month seized all of the company's medical devices at the firm's Union, N.J. facility after finding significant deficiencies in the company's manufacturing processes. During the seizure, Shelhigh was asked to perform a voluntary recall of its products, but it declined.
The FDA is recommending physicians and hospital officials consider using alternative products
"Since these are critical devices implanted into seriously-ill patients, ensuring their sterility is absolutely essential to prevent infection," said Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health.
The FDA said the company's own records indicate a number of sterility test failures and that testing and retesting procedures were not properly performed.
Shelhigh devices include pediatric heart valves, blood flow conduits, surgical patches, dural patches to aid in tissue recovery after neurosurgery, annuloplasty rings to help repair heart valves, and arterial grafts.
The FDA said more information is available at www.fda.gov/cdrh/safety/041907-shelhigh.html and at www.fda.gov/cdrh/medicaldevicesafety/atp/041907-shelhigh.html.
